NCT02257320

TMJ NextGeneration(TM) Feasibility Study

A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: TMJ Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

Detailed description

The study will be conducted at one study center in the U.S. Subjects will be enrolled in the trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2 weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, then five times during the treatment period.

Conditions

• Bruxism

Interventions

Type	Name	Description
DEVICE	TMJ NextGeneration(TM)	The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-02-01
• Completion: 2015-05-01
• First posted: 2014-10-06
• Last updated: 2015-06-10

Locations

2 sites across 1 country: United States